The goal of this Funding Opportunity Announcement (FOA) is
to enable the development of 3D-bioprinted tissue models for drug discovery,
including efficacy studies and toxicology research through a collaborative
arrangement between the 3-D Bioprinting Program at the National Center for
Advancing Translational Sciences (NCATS) and extramural scientists.

NCATS intramural scientists will provide expertise for 3-D
bioprinting, assay development and drug screening stages of the projects.
Extramural investigators will provide appropriate cell resources, disease
expertise and model validation in collaboration with NCATS to perform drug
screening of bioprinted materials. The research application will involve 3-D
bioprinting in a screening format of patient-derived cells supplied by the
extramural investigators, characterization and validation of bioprinted
materials by NCATS investigators and extramural collaborators, and screening
of appropriate molecular libraries.

Key Dates

Posted Date

February 13, 2017

Open Date (Earliest Submission Date)

February 14, 2017

Letter of Intent Due Date(s)

February 28, 2017

Application Due Date(s)

April 14, 2017, by 5:00 PM local time of applicant
organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

No late applications will be accepted for this Funding
Opportunity Announcement.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June, 2017

Advisory Council Review

October, 2017

Earliest Start Date

October, 2017

Expiration Date

April 15, 2017

Due Dates for E.O. 12372

Not Applicable

Required
Application Instructions

It is critical that applicants follow the Research (R) Instructions
in the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH
Guide for Grants and Contracts). Conformance to all requirements (both
in the Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.

The goal of this Funding Opportunity Announcement (FOA) is
to enable the development of 3D-bioprinted tissue models for drug discovery,
including efficacy studies and toxicology research through a collaborative
arrangement between the 3-D Bioprinting Program at the National Center for
Advancing Translational Sciences (NCATS) and extramural scientists. This FOA
seeks to broaden and strengthen translational research collaborations between
basic and clinical researchers, both within and outside NIH, as well as, to
accelerate and enhance translational science through partnerships between NCATS
investigators and extramural investigators by providing research support for
extramural investigators to access the NCATS 3-D Bioprinting Program. For the
initial part of this program, projects will be limited to developing bioprinted
models for skin disorders.

This collaborative translational research between NCATS
intramural investigators and extramural scientists will involve a Cooperative
Research and Development Agreement (CRADA) which will need to be executed for
projects deemed scientifically meritorious by peer review. NCATS intramural
scientists will provide expertise for 3-D bioprinting, assay development and
drug screening stages of the projects. Extramural investigators will provide
appropriate cell resources, disease expertise and model validation in
collaboration with NCATS to perform drug screening of bioprinted materials.

Background

Recent advances in the fields of engineering, biomaterials
science, cell biology, physics and medicine have enabled 3D printing of
biocompatible materials, cells and supporting components into complex 3D
functional living tissues. 3D bioprinting is being applied in many areas from
drug discovery to regenerative medicine. More than 90% of the drugs being
developed fail due to lack of efficacy or because of toxicity, often because of
the use of overly simplistic in vitro cell assays and/or in vivo mouse models
with limited predictive value during the various stages of the drug discovery
process. Three-dimensional (3-D) bioprinting of tissue models using human
primary cells, allogeneic or autologous human iPSC-derived cells that
faithfully recapitulate native tissues can provide more clinically relevant
physiological and pharmacological data. Having access to in vitro human tissue
models that are more predictive of drug efficacy and toxicity in the clinic
could thus have a significant immediate and long-lasting impact not only in
shortening of the timelines and reducing cost of drug discovery but also in
bringing new and better medicines to patients. NCATS has recently set up a 3-D
Bioprinting Program at the NIH. The objective of the 3-D bioprinting program at
NCATS is to generate live human tissues of defined anatomical architecture that
closely resemble native human tissues and organs. The 3-D bioprinting of human
tissue equivalents in microtiter plates allows leveraging of expertise in
tissue engineering/organogenesis, stem cell and disease biology, and
non-invasive detection technologies for tissue characterization and drug
testing. It is expected that the data generated from 3D assays will be more
predictive of in vivo drug performance than that from traditional 2D workflows.

These awards will support studies by the collaborating
extramural investigators to develop 3-D bioprinted constructs using resources
made available through the NCATS Bioprinting Program and to make available
well-characterized iPSC and/or primary cells derived from patients, and
physiological characterization and validation of the 3-D tissue constructs. In
addition, these awards will support assay development and focused drug screens
for identification of novel treatment. It is expected that these 3-D bioprinted
tissues will also provide a better understanding of disease biology, assessment
of candidate therapies for efficacy and safety assessments, and establishment
of a pre-clinical foundation that will inform clinical trial design.

Applications for this program will be submitted by the
extramural institution with the participation of the intramural investigator(s)
integrated into the application as described in the Collaboration Plan. Funded
projects will include an award to the applicant organization which will exclude
funds to support the participation of the NCATS Bioprinting Program. Support
for NCATS intramural contribution will first be determined, then provided, if
applicable by a budget allocation within the NIH. Annual progress reports will
be prepared and submitted by the extramural institutions, with the
participation and input of the intramural investigator(s) and should include
the project findings, publications, data and resource-sharing and impact of the
collaborative project

NCATS has provided the CRADA
template document to help streamline the interaction between NCATS
investigators and extramural scientists. Applicants should review this document
and consult with their institutions about their willingness to agree to the
conditions well in advance of submitting an application to this FOA. The CRADA
will need to be executed after the application has been identified for funding.

Specific
Areas of Interest

Specific Areas of interest for the NCATS Bioprinting Program
include projects involving the bioprinting and initial validation of disease
models where the primary site of pathology involves the skin.

Additional Considerations -

Cells: The availability and use of human primary cells, or
pluripotent stem cells, e.g., iPSC, are strongly encouraged. Multipotent or
unipotent stem cells also may be utilized where appropriate. The current NIH
guidance on stem cell usage can be found at http://stemcells.nih.gov/policy/pages/2009guidelines.aspx.

Collaborations: Collaborative interactions are a critical
aspect of this FOA. In addition to collaborations between NCATS intramural
investigators and extramural scientists, projects may require extensive
collaboration among tissue engineering/tissue biology experts and the disease
experts and clinicians, and engagement of patient advocacy groups.

Important:

Applicants are strongly encouraged to consult with the
Scientific/Research Contacts for the area of science for which they are
planning to develop an application. Early contact provides an opportunity for NCATS
staff to discuss the program scope and goals, and to provide information and
guidance. Other aspects of an application that are unique to this program
including collaboration with Intramural Investigators may also be discussed.

The budget requests for this FOA are more complex and will require
more coordination than those of other programs. Therefore, extramural
investigators are encouraged to begin discussions about logistics and budget
issues with their intramural collaborators and with Grants Management staff in
the early phases of application preparation.

Cooperative Agreement: A support mechanism used when there
will be substantial Federal scientific or programmatic involvement.
Substantial involvement means that, after award, NIH scientific or program
staff will assist, guide, coordinate, or participate in project activities. See
Section VI.2 for additional information about the substantial involvement for
this FOA.

Application Types Allowed

New

The OER
Glossary and the SF424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations
and the submission of a sufficient number of meritorious applications.

NCATS intends to fund an estimate of 1-2 awards,
corresponding to a total of $3,000,000, for fiscal year 2017. Future year
amounts will depend on annual appropriations.

Award Budget

Application budgets are limited to $400,000 in direct
costs per year and should reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the
project period. The maximum project period is 2 years.

NIH grants policies as
described in the NIH
Grants Policy Statement will apply
to the applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible
to apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are not allowed.

Required
Registrations

Applicant
Organizations

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.

eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons
requires organizations to identify at least one Signing Official (SO) and at
least one Program Director/Principal Investigator (PD/PI) account in order to
submit an application.

Grants.gov – Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.
PD(s)/PI(s) should work with their organizational officials to either
create a new account or to affiliate their existing account with the applicant
organization in eRA Commons. If the PD/PI is also the organizational Signing Official,
they must have two distinct eRA Commons accounts, one for each role. Obtaining
an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always encouraged
to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping
applications under review at the same time. This means that the NIH will
not accept:

A new (A0) application that is submitted before issuance of the
summary statement from the review of an overlapping new (A0) or resubmission
(A1) application.

A resubmission (A1) application that is submitted before issuance
of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another
application pending appeal of initial peer review (see NOT-OD-11-101).

Section IV. Application
and Submission Information

1. Requesting an
Application Package

Buttons to access the online ASSIST system or to download
application forms are available in Part
1 of this FOA. See your administrative office for instructions if you plan
to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Research (R) Instructions
in the SF424
(R&R) Application Guide, including Supplemental
Grant Application Instructions except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

All page limitations described in the SF424 Application
Guide and the Table of Page
Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in
the SF424 (R&R) Application Guide and should be used for preparing an
application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must
be followed.

Other
Attachments: The following attachments are required.

Collaboration
Plan

Applications must include a proposed Collaboration Plan,
describing how the proposed collaboration will be maintained throughout the
duration of the award. The following areas should be addressed:

Organizational structure;

Management plan detailing how existing resources, including 3-D
Bioprinting Program at NCATS will be utilized;

Planned interaction and responsibilities of key personnel;

Clear and well described advantage to bringing the intramural and
extramural investigators together in a collaborative partnership

Description of how research teams will communicate (e.g.,
videocast, web meeting, etc.);

Description of any pre-existing Intellectual property; and

While the CRADA may not be in place before the award is made a statement
from the Sponsored Research Office agreeing in principle to the terms of the template
must be included.

The filename "Collaboration Plan-PI-NAME.pdf"
should be used and will be reflected in the final image bookmarking for easy
access by reviewers. The Collaboration Plan is limited to 5 pages.

Milestone
Plan

A Milestone Plan should include:

Milestones that are quantifiable and have clear go/no go
decisions

A detailed project performance and timeline objectives in a
section entitled “Milestone Plan”

A summarized Gantt chart that includes detailed protocol-specific
performance milestones and timeline

The filename "Milestone Plan-PI-NAME.pdf" should
be used and will be reflected in the final image bookmarking for easy access by
reviewers. The Milestone Plan is limited to 3 pages

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide
must be followed.

R&R Budget

All instructions in the SF424 (R&R) Application Guide
must be followed.

Funds from the NIH will be made available through the U18
cooperative agreement award mechanism. Research support for activities related
to the 3-D bioprinting, and drug screening at NCATS will be covered with
internal funds and should not be included in the U18 budget proposal.

The budget request for this FOA must distinguish between
extramural costs and the NIH intramural investigator costs. Extramural
costs are associated with the extramural investigator and the applicant
organization. NIH intramural investigator costs are those required by the
intramural investigator for carrying out the proposed work and which are
specifically identified with the project.

Extramural
Grantee Costs

Extramural costs may include such items as salary support
for the extramural PD/PI and staff at the applicant organization, supplies,
laboratory animals, data analysis, and other allowable costs for work performed
at the (extramural) applicant organization, as well as travel costs for the
extramural investigator(s). Extramural costs may also include travel
costs for in-person meetings with NCATS collaborators.

F&A
(Indirect) Costs: Applicant organizations are reminded that
Facilities and Administrative (F&A) or “indirect costs” are allowable for
only the allowable extramural costs of the project.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Letters
of Support: Applications submitted in response to this FOA must
include a current (i.e. within 2 months of application due date) letter of
collaboration from the Scientific Director of the NCATS Division of Preclinical
Innovation to confirm that the NCATS Bioprinting Facility will be able to
accommodate the proposed research and include documented approval that the
NCATS intramural scientist will be able to collaborate on the project. If
co-funding or in-kind support is planned from any source (non-NIH sources or
NIH sources), letter(s) outlining details of the commitment (e.g. type, amount
and source of support), signed by a business official on organization
letterhead, must be included.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans as provided in the SF424 (R&R)
Application Guide, with the following modification:

All applications, regardless of the amount of direct costs
requested for any one year, should address a Data Sharing Plan.

Appendix:

Do
not use the Appendix to circumvent page limits. Follow all instructions for the
Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report

When conducting clinical research, follow all instructions
for completing PHS Inclusion Enrollment Report as described in the SF424
(R&R) Application Guide.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide
must be followed.

3. Unique Entity Identifier
and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the
requirement for obtaining a unique entity identifier and for completing and
maintaining active registrations in System for Award Management (SAM), NATO
Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and
Grants.gov

4. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to
submit applications before the due date to ensure they have time to make any
application corrections that might be necessary for successful submission. When
a submission date falls on a weekend or Federal
holiday, the application deadline is automatically extended to the next
business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies). Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the application
due date and time. If a Changed/Corrected application is submitted after the
deadline, the application will be considered late. Applications that miss the
due date and time are subjected to the NIH Policy on Late Application
Submission.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically. If you encounter a system issue beyond your control that
threatens your ability to complete the submission process on-time, you must
follow the Guidelines
for Applicants Experiencing System Issues. For assistance with application
submission, contact the Application Submission Contacts in Section VII.

Important
reminders:

All PD(s)/PI(s) must include their eRA Commons ID in
the Credential fieldof the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH. See Section III of this FOA for information on
registration requirements.

The applicant organization must ensure that the DUNS
number it provides on the application is the same number used in the
organization’s profile in the eRA Commons and for the System for Award Management.
Additional information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness and compliance with application instructions by the Center for
Scientific Review and responsiveness by components
of participating organizations, NIH. Applications that are incomplete, non-compliant
and/or nonresponsive will not be reviewed.

Applications Involving the NIH Intramural Research
Program

The requests by NIH intramural scientists will be limited to
the incremental costs required for participation. As such, these
requests will not include any salary and related fringe benefits for career,
career conditional or other Federal employees (civilian or uniformed service)
with permanent appointments under existing position ceilings or any costs
related to administrative or facilities support (equivalent to Facilities and
Administrative or F&A costs). These costs may include salary for staff to
be specifically hired under a temporary appointment for the project, consultant
costs, equipment, supplies, travel, and other items typically listed under
Other Expenses. Applicants should indicate the number of person-months devoted
to the project, even if no funds are requested for salary and fringe benefits.

If selected, appropriate funding will be provided by the NIH
Intramural Program. NIH intramural scientists will participate in this program
as PDs/PIs in accord with the Terms and Conditions provided in this FOA.
Intellectual property will be managed in accord with established policy of the
NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent
rights for inventions developed in NIH facilities are NIH property unless NIH
waives its rights.

Because the extramural application will include the
collaboration with an intramural scientist, no funds for the support of the
intramural scientist may be requested in the application. The intramural
scientist may submit a separate request for intramural funding as described
above.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in the policy.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an
important problem or a critical barrier to progress in the field? Is there a
strong scientific premise for the project? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators,
and other researchers well suited to the project? If Early Stage Investigators
or New Investigators, or in the early stages of independent careers, do they
have appropriate experience and training? If established, have they
demonstrated an ongoing record of accomplishments that have advanced their
field(s)? If the project is collaborative or multi-PD/PI, do the investigators
have complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?

Specific to this FOA:

Is the Collaboration Plan well defined with identifiable
responsibilities for the NIH intramural investigator and the extramural
applicant?

Is there a clear and well described advantage to bringing the
intramural and extramural investigators together in a collaborative partnership?

Innovation

Does the application challenge and
seek to shift current research or clinical practice paradigms by utilizing
novel theoretical concepts, approaches or methodologies, instrumentation, or
interventions? Are the concepts, approaches or methodologies, instrumentation,
or interventions novel to one field of research or novel in a broad sense? Is a
refinement, improvement, or new application of theoretical concepts, approaches
or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy,
methodology, and analyses well-reasoned and appropriate to accomplish the
specific aims of the project? Have the investigators presented strategies to
ensure a robust and unbiased approach, as appropriate for the work proposed? Are
potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be managed? Have
the investigators presented adequate plans to address relevant biological
variables, such as sex, for studies in vertebrate animals or human subjects?

Specific to this FOA:

Is a plan for management of the collaboration clearly presented,
with well-defined descriptions of what each participant proposes to provide to
the collaborative partnership?

If the project involves human
subjects and/or NIH-defined clinical research, are the plans to address 1) the
protection of human subjects from research risks, and 2) inclusion (or exclusion)
of individuals on the basis of sex/gender, race, and ethnicity, as well as the
inclusion or exclusion of children, justified in terms of the scientific goals
and research strategy proposed?

Environment

Will the scientific environment in
which the work will be done contribute to the probability of success? Are the
institutional support, equipment and other physical resources available to the
investigators adequate for the project proposed? Will the project benefit from
unique features of the scientific environment, subject populations, or
collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers
will evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Milestones

Are the steps and milestones clearly defined? Are the
milestones feasible, well developed and quantifiable with regard to specific
goals and accomplishments?

Collaboration
Plan

Does the Collaboration Plan adequately describe how
the proposed collaboration will be maintained throughout the duration of the
award?

RFA/PAR only: Additional Review Criteria may be
added. Use “Heading 4 indent” for the names of the criteria.

Protections for Human Subjects

For research that involves human
subjects but does not involve one of the six categories of research that are
exempt under 45 CFR Part 46, the committee will evaluate the justification for
involvement of human subjects and the proposed protections from research risk
relating to their participation according to the following five review
criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3)
potential benefits to the subjects and others, 4) importance of the knowledge
to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human
subjects and meets the criteria for one or more of the six categories of
research that are exempt under 45 CFR Part 46, the committee will evaluate: 1)
the justification for the exemption, 2) human subjects involvement and
characteristics, and 3) sources of materials. For additional information on
review of the Human Subjects section, please refer to the Guidelines for the Review of Human
Subjects.

Inclusion of Women, Minorities,
and Children

When the proposed project involves
human subjects and/or NIH-defined clinical research, the committee will
evaluate the proposed plans for the inclusion (or exclusion) of individuals on
the basis of sex/gender, race, and ethnicity, as well as the inclusion (or
exclusion) of children to determine if it is justified in terms of the
scientific goals and research strategy proposed. For additional information on
review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion
in Clinical Research.

Vertebrate Animals

The committee will evaluate the
involvement of live vertebrate animals as part of the scientific assessment
according to the following criteria: (1) description of proposed procedures
involving animals, including species, strains, ages, sex, and total number to
be used; (2) justifications for the use of animals versus alternative models
and for the appropriateness of the species proposed; (3) interventions to
minimize discomfort, distress, pain and injury; and (4) justification for
euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia
of Animals. Reviewers will assess the use of chimpanzees as they would any
other application proposing the use of vertebrate animals. For additional
information on review of the Vertebrate Animals section, please refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether
materials or procedures proposed are potentially hazardous to research
personnel and/or the environment, and if needed, determine whether adequate
protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Applications from Foreign
Organizations

Not Applicable

Select Agent Research

Reviewers will assess the
information provided in this section of the application, including 1) the
Select Agent(s) to be used in the proposed research, 2) the registration status
of all entities where Select Agent(s) will be used, 3) the procedures that will
be used to monitor possession use and transfer of Select Agent(s), and 4) plans
for appropriate biosafety, biocontainment, and security of the Select Agent(s).

For projects involving key biological and/or chemical resources,
reviewers will comment on the brief plans proposed for identifying and ensuring
the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the
budget and the requested period of support are fully justified and reasonable
in relation to the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by NCATS, in
accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in
response to this FOA.

Applications will be assigned to the appropriate NIH
Institute or Center. Applications will compete for available funds with all
other recommended applications submitted in response to this FOA. Following
initial peer review, recommended applications will receive a second level of
review by the appropriate national Advisory Council or Board. The following
will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

Compliance with resource sharing policies.

Likelihood of effective collaboration between the PD(s)/PI(s) of
the applicant institution and the NIH Intramural Investigator.

Utilization of unique research partnership opportunities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons. Refer to Part 1 for dates for peer review, advisory council
review, and earliest start date.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA)
will be provided to the applicant organization for successful applications. The
NoA signed by the grants management officer is the authorizing document and
will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described
in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be
subject to terms and conditions found on the Award
Conditions and Information for NIH Grants website. This includes any
recent legislation and policy applicable to awards that is highlighted on this
website.

Recipients of federal financial
assistance (FFA) from HHS must administer their programs in compliance with
federal civil rights law. This means that recipients of HHS funds must ensure
equal access to their programs without regard to a person’s race, color,
national origin, disability, age and, in some circumstances, sex and religion.
This includes ensuring your programs are accessible to persons with limited
English proficiency. HHS recognizes that research projects are often limited
in scope for many reasons that are nondiscriminatory, such as the principal
investigator’s scientific interest, funding limitations, recruitment
requirements, and other considerations. Thus, criteria in research protocols
that target or exclude certain populations are warranted where
nondiscriminatory justifications establish that such criteria are appropriate
with respect to the health or safety of the subjects, the scientific study
design, or the purpose of the research.

For additional guidance regarding how the provisions apply
to NIH grant programs, please contact the Scientific/Research Contact that is
identified in Section VII under Agency Contacts of this FOA. HHS provides
general guidance to recipients of FFA on meeting their legal obligation to take
reasonable steps to provide meaningful access to their programs by persons with
limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html.
The HHS Office for Civil Rights also provides guidance on complying with civil
rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html;
and http://www.hhs.gov/ocr/civilrights/understanding/index.html.
Recipients of FFA also have specific legal obligations for serving qualified
individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
Please contact the HHS Office for Civil Rights for more information about
obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS
Departmental goal to ensure access to quality, culturally competent care,
including long-term services and supports, for vulnerable populations. For
further guidance on providing culturally and linguistically appropriate
services, recipients should review the National Standards for Culturally and
Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in
Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal
Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal
Awardee Performance and Integrity Information System (FAPIIS) requirements.
FAPIIS requires Federal award making officials to review and consider
information about an applicant in the designated integrity and performance
system (currently FAPIIS) prior to making an award. An applicant, at its
option, may review information in the designated integrity and performance
systems accessible through FAPIIS and comment on any information about itself
that a Federal agency previously entered and is currently in FAPIIS. The
Federal awarding agency will consider any comments by the applicant, in
addition to other information in FAPIIS, in making a judgement about the
applicant’s integrity, business ethics, and record of performance under Federal
awards when completing the review of risk posed by applicants as described in
45 CFR Part 75.205 “Federal awarding agency review of risk posed by
applicants.” This provision will apply to all NIH grants and cooperative agreements
except fellowships.

Cooperative Agreement Terms and Conditions of Award

The
following special terms of award are in addition to, and not in lieu of,
otherwise applicable U.S. Office of Management and Budget (OMB) administrative
guidelines, U.S. Department of Health and Human Services (DHHS) grant
administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable
when State and local Governments are eligible to apply), and other HHS, PHS,
and NIH grant administration policies.

The administrative and funding instrument used for this
program will be the cooperative agreement, an "assistance" mechanism
(rather than an "acquisition" mechanism), in which substantial NIH
programmatic involvement with the awardees is anticipated during the performance
of the activities. Under the cooperative agreement, the NIH purpose is to
support and stimulate the recipients' activities by involvement in and
otherwise working jointly with the award recipients in a partnership role; it
is not to assume direction, prime responsibility, or a dominant role in the
activities. Consistent with this concept, the dominant role and prime
responsibility resides with the awardees for the project as a whole, although
specific tasks and activities may be shared among the awardees and the NIH as
defined below.

The
PD(s)/PI(s) will have the primary responsibility for:

The PD(s)/PI(s) will have the primary responsibility to
define objectives and approaches, and to plan, conduct, analyze, and publish
results, interpretations, and conclusions of their studies.

Identifying specific milestones that will be achieved during the
project period.

Agreeing to participate in the overall coordination of research
efforts. This participation includes collaboration and consultation with NIH
investigators, and the sharing of information, data, and research materials.

Accepting and agreeing to participate in the cooperative nature
of the program.

Agreeing to participate to periodic WebEx-based calls by the NIH
during the award period. In addition, at least one in-person annual meetings
with NCATS staff will be required. The PI and up to one other key personnel
with complementary expertise are required to attend these meetings. Funds to
attend these workshops should be budgeted in the application.

NIH
staff have substantial programmatic involvement that is above and beyond the
normal stewardship role in awards, as described below:

The NIH Project Coordinator is expected to have primary
responsibility for a substantial portion of the proposed research, and provide
advice and technical assistance as needed. The NIH Project Coordinator will
also participate in the analysis, interpretation, and reporting of findings in
the scientific literature, to the community at large and to the public policy
community within the Federal government through various media, as appropriate.
The NIH Project Coordinator is subject to the same publication/authorship
policies as the official NIH publication policy.

The NIH Project Coordinator will have substantial programmatic
involvement in the study and will be responsible for the normal programmatic
stewardship of the award. The Program Coordinator will have decision-making
authority on matters of budgetary and funding actions, grants management
actions, and management of intellectual property issues. The responsibility for
final decision making may reside with Senior Institute management, separate
organizational components and/or oversight committees.

In addition, a separate NIAID Program Official will be
responsible for normal program stewardship of the cooperative agreement award.

The NIH reserves the right to phase out or curtail the study
(or an individual award) in the event of (a) failure to develop or implement a
mutually agreeable protocol, (b) substantial shortfall in subject recruitment,
consortium participation and collaboration with other awardees, (c) substantive
changes in the agreed-upon methodologies and tools with which NIH cannot
concur, (d) human subject ethical issues that may dictate a premature
termination, or (e) results that substantially diminish the scientific value of
study continuation.

Areas
of Joint Responsibility include:

Since the purpose of this FOA is to establish and/or further
develop collaborative arrangements between extramural and intramural
investigators, many responsibilities are shared between awardees and NIH staff
and will require close coordination.

All responsibilities will be divided between awardees and
NIH staff, as described above.

While the annual progress reports will be prepared and
submitted by the extramural institutions, the participation and input of the
intramural investigator(s) is required. The report should include the project
findings, publications and impact of the project. This will be evaluated by
the program official/IC program director.

Dispute
Resolution:

Any disagreements that may arise in scientific or
programmatic matters (within the scope of the award) between award recipients
and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel
composed of three members will be convened. It will have three members: a
designee of the awardee, a NIH designee, and a third designee with expertise in
the relevant area who is chosen by the other two. This special dispute resolution
procedure does not alter the awardee's right to appeal an adverse action that
is otherwise appealable in accordance with PHS regulation 42 CFR Part 50,
Subpart D and DHHS regulation 45 CFR Part 16.

T&C
Inclusions and Modifications

The Terms and Conditions of Award will include references to
the currently approved versions of the Collaboration Plan and the Multiple
PD(s)/PI(s) Leadership Plan, if applicable, and the Sharing Plans for Resources
and Data. Before the initial award is made, NIH and the awardees may negotiate
changes or additions to the versions of these plans in the application. Future
changes or additions to these plans may be developed by the NIH and the
PD(s)/PI(s). Changes will be documented by an exchange of correspondence and the
updated plans will become part of the Terms and Conditions of a revised Notice
of Award.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH
Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

In accordance with the regulatory requirements provided at
45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have
currently active Federal grants, cooperative agreements, and procurement
contracts from all Federal awarding agencies with a cumulative total value
greater than $10,000,000 for any period of time during the period of performance
of a Federal award, must report and maintain the currency of information
reported in the System for Award Management (SAM) about civil, criminal,
and administrative proceedings in connection with the award or performance of a
Federal award that reached final disposition within the most recent five-year
period. The recipient must also make semiannual disclosures regarding
such proceedings. Proceedings information will be made publicly available
in the designated integrity and performance system (currently FAPIIS). This is
a statutory requirement under section 872 of Public Law 110-417, as amended (41
U.S.C. 2313). As required by section 3010 of Public Law 111-212, all
information posted in the designated integrity and performance system on or after
April 15, 2011, except past performance reviews required for Federal
procurement contracts, will be publicly available. Full reporting requirements
and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and
Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.